NCT01987739 is a Phase 1 clinical trial of 200 mg almorexant in Abuse Potential Study, sponsored by Midnight Pharma, LLC.

Who is sponsoring NCT01987739?

NCT01987739 is sponsored by Midnight Pharma, LLC.

What drugs are being tested in NCT01987739?

Interventions in NCT01987739: 200 mg almorexant, 400 mg almorexant, 1000 mg almorexant, 20 mg zolpidem, 40 mg zolpidem, placebo.

What condition does NCT01987739 study?

NCT01987739 studies Abuse Potential Study.

Is NCT01987739 still recruiting?

NCT01987739 is currently completed. Last updated 11 February 2016.

Last reviewed 2016-02-11 · How we verify

NCT01987739

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Single Center, Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, Six-way Crossover Single-dose Study to Evaluate the Relative Abuse Potential of Almorexant in Recreational Central Nervous System (CNS) Depressant Drug Users

Completed Phase 1 Last updated 11 February 2016

What this trial tests

Phase 1 trial testing 200 mg almorexant in Abuse Potential Study in 42 participants. Completed in 1 February 2010.

Timeline

1 September 2009

Primary endpoint
1 February 2010

1 February 2010

Quick facts

Lead sponsor	Midnight Pharma, LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Enrollment	42
Start date	1 September 2009
Primary completion	1 February 2010
Estimated completion	1 February 2010

Drugs / interventions tested

200 mg almorexant — full drug profile →
400 mg almorexant — full drug profile →
1000 mg almorexant — full drug profile →
20 mg zolpidem — full drug profile →
40 mg zolpidem — full drug profile →
placebo

Conditions studied

Abuse Potential Study — all drugs for Abuse Potential Study →

Sponsor

Midnight Pharma, LLC — full company profile →

Who can join

Adults 18 to 55, any sex, with Abuse Potential Study. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Maximum effect (Emax) over 24 h post-dose for "At the moment" Drug Liking Visual Analogue Scale (VAS) score during each Treatment Visit
Time frame: 24 hours
Emax was determined on a Drug Liking VAS which assessed positive and negative drug effects (Griffiths 2003, Milovan 2009, Schoedel 2008). VAS items were displayed on two screen images. Using a mouse, the subject positioned the cursor over the small vertical box ("slider") and clicked on it to move it left or right on a scale of 0-100. To register the response, the subject then pressed the "OK" but

Sponsor's own description

This was a six-way crossover study with six single-dose treatment sessions. The profile of acute effects on abuse potential measures of different almorexant doses was compared to that of placebo and two doses of zolpidem

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01987739 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Midnight Pharma, LLC
Last refreshed: 11 February 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01987739.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing